ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE

N/A

Manufactured by Walgreens

310 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Walgreens. The most commonly reported adverse reactions for ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE include CHRONIC KIDNEY DISEASE, DIZZINESS, COVID-19, DIARRHOEA, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE.

Top Adverse Reactions

CHRONIC KIDNEY DISEASE11 reports
DIZZINESS9 reports
COVID 198 reports
DIARRHOEA8 reports
NAUSEA8 reports
PNEUMONIA8 reports
ACUTE KIDNEY INJURY7 reports
DRUG INEFFECTIVE7 reports
END STAGE RENAL DISEASE7 reports
RENAL FAILURE7 reports
HEADACHE6 reports
ABDOMINAL DISCOMFORT5 reports
COUGH5 reports
DYSPNOEA5 reports
FALL5 reports
PRODUCT ADMINISTRATION INTERRUPTED5 reports
PYREXIA5 reports
SOMNOLENCE5 reports
SURGERY5 reports
VOMITING5 reports
ANXIETY4 reports
FATIGUE4 reports
HEART RATE INCREASED4 reports
MALAISE4 reports
NASOPHARYNGITIS4 reports
TUBULOINTERSTITIAL NEPHRITIS4 reports
WEIGHT DECREASED4 reports
ASTHENIA3 reports
DECREASED APPETITE3 reports
DYSPEPSIA3 reports
DYSPHONIA3 reports
FOREIGN BODY IN THROAT3 reports
HYPERTENSION3 reports
ILLNESS3 reports
INFECTION3 reports
INSOMNIA3 reports
NASAL CONGESTION3 reports
NEPHROGENIC ANAEMIA3 reports
PAIN3 reports
PRODUCT DOSE OMISSION ISSUE3 reports
PRODUCT USE IN UNAPPROVED INDICATION3 reports
RENAL INJURY3 reports
SEIZURE3 reports
UPPER RESPIRATORY TRACT INFECTION3 reports
URINARY TRACT INFECTION3 reports
CHEST DISCOMFORT2 reports
CHEST PAIN2 reports
DEHYDRATION2 reports
DEPRESSION2 reports
DISEASE RECURRENCE2 reports
DRY SKIN2 reports
ERYTHEMA2 reports
FEELING ABNORMAL2 reports
FLATULENCE2 reports
FLUSHING2 reports
GASTRIC BYPASS2 reports
HOSPITALISATION2 reports
HYPERHIDROSIS2 reports
HYPERPARATHYROIDISM SECONDARY2 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION2 reports
INCORRECT DOSE ADMINISTERED2 reports
INFLUENZA2 reports
INSURANCE ISSUE2 reports
LOSS OF CONSCIOUSNESS2 reports
MEMORY IMPAIRMENT2 reports
MIGRAINE2 reports
MUSCULOSKELETAL STIFFNESS2 reports
OFF LABEL USE2 reports
OSTEOPOROSIS2 reports
PANIC ATTACK2 reports
PHARYNGITIS2 reports
POOR VENOUS ACCESS2 reports
PRODUCT COMPLAINT2 reports
PRURITUS2 reports
PULMONARY MASS2 reports
RENAL DISORDER2 reports
RENAL IMPAIRMENT2 reports
RESTLESS LEGS SYNDROME2 reports
RESTLESSNESS2 reports
SINUS CONGESTION2 reports
SINUSITIS2 reports
SKIN INFECTION2 reports
STRESS2 reports
TACHYCARDIA2 reports
THERAPEUTIC RESPONSE UNEXPECTED2 reports
WEIGHT INCREASED2 reports
WHITE BLOOD CELL COUNT INCREASED2 reports
ABDOMINAL PAIN1 reports
ABDOMINAL PAIN LOWER1 reports
ABDOMINAL PAIN UPPER1 reports
ABNORMAL DREAMS1 reports
ABORTION INFECTED1 reports
ABORTION SPONTANEOUS1 reports
ACUTE LEFT VENTRICULAR FAILURE1 reports
ACUTE MYOCARDIAL INFARCTION1 reports
ACUTE RESPIRATORY FAILURE1 reports
AFFECTIVE DISORDER1 reports
ALOPECIA1 reports
AMENORRHOEA1 reports
ANAEMIA1 reports

Report Outcomes

Out of 88 classified reports for ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE:

Serious 67.0%Non-Serious 33.0%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female56 (72.7%)
Male21 (27.3%)

Reports by Age

Age 222 reports
Age 332 reports
Age 372 reports
Age 402 reports
Age 502 reports
Age 572 reports
Age 592 reports
Age 632 reports
Age 702 reports
Age 712 reports
Age 201 reports
Age 241 reports
Age 281 reports
Age 301 reports
Age 351 reports
Age 381 reports
Age 441 reports
Age 461 reports
Age 471 reports
Age 491 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE?

This profile reflects 310 FDA FAERS reports that mention ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE?

Frequently reported terms in FAERS include CHRONIC KIDNEY DISEASE, DIZZINESS, COVID-19, DIARRHOEA, NAUSEA, PNEUMONIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE?

Labeling and FAERS entries often list Walgreens in connection with ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.